A Phase II Trial of CyberKnife Stereotactic Radiosurgery to Prostate Tumors
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 1/27/2018 |
| Start Date: | January 2008 |
| End Date: | February 2019 |
Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Emulating Homogenous Dose Distribution
The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients
with early stage prostate cancer.
The investigators hypothesize that hypofractionated stereotactic radiotherapy via the
CyberKnife® can deliver tumor ablating doses of radiation to prostate tumors safely and
effectively while sparing the adjacent tissues (rectum, bladder, ureters, urethra, penile
bulb, and bowel) from receiving damaging doses of radiation.
with early stage prostate cancer.
The investigators hypothesize that hypofractionated stereotactic radiotherapy via the
CyberKnife® can deliver tumor ablating doses of radiation to prostate tumors safely and
effectively while sparing the adjacent tissues (rectum, bladder, ureters, urethra, penile
bulb, and bowel) from receiving damaging doses of radiation.
The CyberKnife system is a type of radiation machine that uses a special system to precisely
focus large doses of x-rays (radiation) on the tumor. The device is designed to concentrate
large doses of radiation onto the tumor so that injury from radiation to the nearby normal
tissue will be minimal.
focus large doses of x-rays (radiation) on the tumor. The device is designed to concentrate
large doses of radiation onto the tumor so that injury from radiation to the nearby normal
tissue will be minimal.
Inclusion Criteria:
- Male Age ≥ 21
- Histologically proven prostate adenocarcinoma
- Clinical stage T1b-T2b, N0-Nx, M0-Mx (AJCC 6th Edition)
- PSA ≤ 20 ng/ml
- Prostate volume ≤ 100 cc
Patients belonging in one of the following risk groups:
- Low:
- CS T1b-T2a and Gleason 2-6 and PSA ≤ 10
- Intermediate:
- CS T2b and Gleason 2-6 and PSA ≤ 10, OR
- CS T1b-T2b, and Gleason 2-6 and PSA ≤ 20 ng/ml OR Gleason 7 and PSA ≤ 10 ng/ml
Exclusion Criteria:
- Any histology other than adenocarcinoma
- Age < 21
- KPS <= 40 <70
- ECOG Performance Status ≥ 2
- Patient weight >350 lbs. (table limitation)
- Prior XRT to prostate or lower pelvis
- Prior surgery or cryotherapy to prostate
- Implanted hardware or other material that would prohibit appropriate treatment
planning or treatment delivery, in the investigator's opinion
- Chemotherapy for a malignancy in the last 5 years
- History of an invasive malignancy (other than this prostate cancer, or basal or
squamous skin cancers) in the last 5 years
- Hormone ablation for 2 months prior to enrollment, or during treatment
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